Japanese Off-Pump Coronary Artery Revascularization Investigation

UMIN ID: C000000124

Registered date:01/11/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Patients with two or three vessel coronary artery disease who need coronary artery bypass grafting
• Date of first enrollment: 2002/07/01
• Target sample size: 280
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Coronary artery bypass grafting with cardiopulmonary bypass
Coronary artery bypass grafting without cardiopulmonary bypass

Outcome(s)

• Primary Outcome: The primary endpoints were 3-year cardiac events after CABG including acute myocardial infarction, admission by angina pectoris or congestive heart failure, cardiac death, and re-intervention.
• Secondary Outcome: The secondary endpoints were completeness of revascularization, early clinical outcomes, and neurocognitive function.

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: The exclusion criteria were as follows: acute MI; an age of more than 70 years; an indication for additional surgical procedures; documented history of stroke; severe ascending aortic calcification by CT scanning; carotid arterial stenosis of more than 75% by Duplex scanning; acute Q-wave myocardial infarction which necessitates emergency operation; left ventricular ejection fraction of less than 30%; serum creatinine level of higher than 2.0 mg/dL; liver cirrhosis; chronic obstructive pulmonary disease that needs a bronchodilator or steroid; pulmonary hypertension with a mean pulmonary artery pressure >25mmHg; other comorbidity which is not appropriate for CPB such as anomalous coagulation, cancer, and an inability to provide written informed consent.

Related Information

• Primary Sponsor: National Cardiovascular Center
• Source(s) of Monetary Support: Japanese Ministry of Health, Labor, and Welfare